Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Drug: Angiotensin Converting Enzyme Inhibitor; Other: No ACE Inhibitor

• Registration Number: NCT00848250
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2017-05-01
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Results First Posted: 2017-07-26
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
• Patients must be taking an ACE inhibitor prior to their operation

Exclusion Criteria

• Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
• Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
• Pregnancy as ruled out by standard of care screening procedures.
• Individuals whose weight is less than 3.5 kg at the time of enrollment.
• Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACE inhibitor	Angiotensin Converting Enzyme Inhibitor	Patients already on an ACE inhibitor will continue it until the day of surgery
No ACE inhibitor	No ACE Inhibitor	Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery

Primary Outcome Measures

Name	Time	Method
t-PA (Tissue-type Plasminogen Activator) Antigen	Baseline (prior to surgery) to postoperative day 1
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen	Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1

Secondary Outcome Measures

Name	Time	Method
IL-6 (Interleukin-6)	Baseline (pre-surgery) to postoperative day 1
(MAP) Mean Arterial Blood Pressure	Baseline (prior to surgery) to postoperative day 1
Postoperative Bleeding	24 hours	Chest tube output at 4 and 24 hours after completion of surgery
Postoperative Renal Function	Baseline (prior to surgery) to postoperative day 1	Acute kidney injury occurring
IL-8 (Interleukin-8)	Baseline (pre-surgery) to postoperative day 1

Trial Locations

Locations (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States